Medscape Dermatology asked Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, North Carolina, to share his expertise on the impact biosimilar versions of FDA-approved biologics are having in dermatology.

How do you characterize the availability of biosimilars for treating psoriasis, atopic dermatitis, and other skin diseases? Can you provide a snapshot of what’s going on right now?

Feldman: It was revolutionary when biologics came out about 20 years ago, for example, with Humira [adalimumab]. Now we’re seeing multiple biosimilars of Humira come out. Stelara [ustekinumab] was another quantum leap when it came out, and now multiple Stelara biosimilars are available. We don’t prescribe Humira and Stelara as much anymore because newer drugs like the interleukin (IL)-17 and IL-23 inhibitors came out that are better. But so far, we don’t have biosimilars for those.

Biosimilars are often promoted as a less costly option compared with biologics. Has that been your experience?

Feldman: You have to ask whose cost we’re talking about. If you’re talking about the cost to the doctor — we’re not paying for the drug — but we are paying our staff to get the drugs approved. Having more options creates more headaches, especially if an insurer says they won’t cover this biosimilar and they will cover that one. Then, 6 months later, they might change their mind because they got a better deal. The cost to the insurer is probably less [for a biosimilar], or else they wouldn’t be using them. If you bring down the cost to the insurer, it presumably helps lower the cost of premiums for patients globally.

But for individual patients, I don’t see how it can reduce the cost because patients paying for the originators had support programs. The copay support programs were so good for the innovator products, and it’s hard to know to what extent the biosimilar companies will have equal support programs. It’s been great being a psoriasis specialist these last 20 years because, although these drugs were expensive, there were programs in place to help make them affordable.

Do you have any advice for other dermatologists considering whether or not to select a biosimilar for a particular patient? What are the factors that go into the decision?

Feldman: There is only one factor, and that is which agent the insurance company is going to cover. Patients can ask for a particular brand name, and they can pay for it themselves if they want to spend thousands of dollars a year. But nobody wants to do that. So the decision will be in the hands of the insurer.

Do your patients generally understand the difference between a biologic and a biosimilar?

Feldman: No, but I don’t think a lot of people do. The biologics are such large, complex glycoproteins with tertiary and quaternary folding. They are so complicated that no one can duplicate the original one. But they work the same.

When people hear that, the first thing they think is then the biosimilars cannot be the same drug. What is important to understand is that nobody — not even the originator company — can duplicate their own drug. Every batch is different from every other batch.

We get much more information given to us about the similarity of the biosimilar than we do about different batches of the originator. Even though the biosimilars are not identical, they are sufficiently similar in efficacy and safety that there is no clinically meaningful difference. Once patients understand this, they generally accept the biosimilars.

Access can be an issue for biologics. Will it be any easier for patients with biosimilars?

Feldman: There are articles stating that biosimilars will decrease costs and increase patient access. In terms of access, let’s say biosimilars cost 20% less at first. If the overall cost is $1 billion, that’s $200 million, so there are some savings there. And let’s say after a few years, the cost decreases to 50%. So instead of being a $50,000 drug, you can get it for $25,000 a year. Do you think the insurers will say now that it’s $25,000 a year, we’ll let everyone have it with no restrictions on its use?

Access has been very good with all the support programs. If the company support programs end and insurers start charging patients $100 or $200 a month, then access might go down.

Are there any misconceptions about biosimilars in dermatology that you would like to clear up?

Feldman: The biggest misconception is that they are so different from the originator that you cannot trust them. If anything, they are probably better than the originator. As both biologics and biosimilars have evolved, they have become less immunogenic.

Is it true that interchangeability can sometimes be an issue?

Feldman: Yes. This goes back to people thinking you’re not going to have the same response with a biosimilar, and additional studies are needed, such as a switch study. But people switch between batches of the innovator all the time. So a switch study for a biosimilar doesn’t make any sense to me.

Is there anything else that we have not discussed that is relevant to biosimilars in dermatology?

Feldman: The biosimilars, as far as I’m concerned, are just like another batch of the innovator. Also, these drugs, biosimilar or innovator, tend to stop working overtime. People develop antibodies against them, and they stop working. When that happens, patients might think, “Oh, it’s because I switched to that cheap biosimilar. I should have stayed on the innovator drug.” Or maybe they get a headache or an upset stomach, and they are going to blame it on the biosimilar. We’re going to have to hold people’s hands through periods of change. Hopefully, people understand that a biosimilar is, in essence, very, very similar to the different batches of the innovator drug.

Feldman reported receiving research, speaking, and/or consulting support from Eli Lilly and Company, GlaxoSmithKline/Stiefel, AbbVie, Janssen, Alovtech, VTV Therapeutics, Bristol-Myers Squibb, Samsung, Pfizer, Alumis, Boehringer Ingelheim, Oruka, Amgen, Dermavant, Arcutis, Novartis, UCB, Helsinn, Sun Pharma, Almirall, Galderma, Leo Pharma, Mylan, Celgene, Ortho Dermatology, Menlo, Merck & Co., Qurient, Forte, Arena, Biocon, Accordant, Argenx, Sanofi, Regeneron, the National Biological Corporation, Caremark, Teladoc, BMS, Ono, Micreos, Eurofins, Informa, UpToDate, Verrica, and the National Psoriasis Foundation. He is reported to be the founder and part owner of Causa Research and holds stock in Sensal Health.